C18.4 C78.0
Conditions
Interventions
Group 1: pulmonary metastasectomy
Group 2: standard of care (systemic treatment)
Sponsors
Universitätsklinikum FreiburgKlinik für Thoraxchirurgie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed colorectal adenocarcinoma 2. = 3 technically resectable (R0) pulmonary metastases 3. Male or female patients aged = 18 years without upper age limit 4. Resected primary tumour with intent to cure (sole prior (chemo) radiation of a rectal cancer with documented complete remission is permitted) 5. In case of previous treatment of hepatic metastases: no radiologic sign of residual hepatic disease at the time of trial randomisation 6. A minimum of 12 weeks of systemic therapy with the last treatment applied within 6 months prior to randomisation 7. Good performance status (ECOG 0-1)
Exclusion criteria
Exclusion criteria: 1. Active extra-thoracic disease (including primary tumour in situ) 2. Prior resection of lung metastases 3. Requirement of a pneumonectomy to achieve complete resection 4. Other malignancy in the past 5 years (except non-melanoma skin cancer or in situ cancer) 5. Histologically proven intrathoracic lymph node metastasis (except resectable single level mediastinal, hilar and pulmonary)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Progression-free survival (PFS) - Complete remission - Quality of life (EORTC QLQ-C30, QLQ-CR29 and QLQ-LC29) - Safety (Arm A only) | — |
Countries
Germany
Contacts
Public ContactJohannes Bausch
Universitätsklinikum Freiburg, Zentrum Klinische Studien
Outcome results
None listed